Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
Study NCT ID:
NCT07386366
Status:
RECRUITING
Last Update Posted:
2026-02-04
First Post:
2026-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Wound Healing and Bacterial Adherence With Triclosan-Coated Sutures After Mandibular Impacted Third Molar Surgery
Sponsor:
University of Medicine and Pharmacy at Ho Chi Minh City
Organization:
Study Overview
Official Title:
Evaluation of Soft Tissue Healing and Antibacterial Effectiveness of Triclosan-Coated Polyglactin 910 Sutures After Impacted Mandibular Third Molar Surgery: A Randomized Double-Blind Split-Mouth Clinical Trial
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if triclosan-coated absorbable stitches (polyglactin 910 sutures coated with triclosan, an antibacterial agent) help soft tissue heal better and have fewer bacteria stuck to the stitches after lower impacted wisdom tooth surgery in adults aged 18 to 35 years.
The main questions it aims to answer are:
1. Does triclosan-coated polyglactin 910 suture lead to better soft-tissue wound healing than non-coated polyglactin 910 suture on postoperative days 3, 5, and 7 after mandibular impacted third molar surgery?
2. Does triclosan-coated polyglactin 910 suture result in a lower oral bacterial load adhered to the suture material than non-coated polyglactin 910 suture on postoperative days 3, 5, and 7 after mandibular impacted third molar surgery?
Participants will:
* Have surgery to remove two similar lower impacted wisdom teeth (one on each side)
* Receive triclosan-coated stitches on one side and standard stitches on the other side, with the side assignment chosen at random
* Return for follow-up visits on day three, day five, and day seven after surgery for healing checks, simple ratings of pain and swelling, and collection of a small stitch sample for bacterial testing.
The main questions it aims to answer are:
1. Does triclosan-coated polyglactin 910 suture lead to better soft-tissue wound healing than non-coated polyglactin 910 suture on postoperative days 3, 5, and 7 after mandibular impacted third molar surgery?
2. Does triclosan-coated polyglactin 910 suture result in a lower oral bacterial load adhered to the suture material than non-coated polyglactin 910 suture on postoperative days 3, 5, and 7 after mandibular impacted third molar surgery?
Participants will:
* Have surgery to remove two similar lower impacted wisdom teeth (one on each side)
* Receive triclosan-coated stitches on one side and standard stitches on the other side, with the side assignment chosen at random
* Return for follow-up visits on day three, day five, and day seven after surgery for healing checks, simple ratings of pain and swelling, and collection of a small stitch sample for bacterial testing.
Detailed Description:
This randomized, double-blind, two-period crossover clinical trial evaluates the antibacterial performance of triclosan-coated polyglactin 910 sutures compared with standard (non-coated) polyglactin 910 sutures following impacted mandibular third molar surgery. The study is designed to determine whether triclosan coating reduces bacterial adherence/amount on suture material during early postoperative healing and to examine associated soft-tissue healing.
Each participant undergoes two separate surgical extractions of impacted mandibular third molars performed on different occasions 4 weeks apart. The operated side (right or left) may vary by case and is recorded; treatment assignment is based on surgery order (period 1 versus period 2). Participants are randomized to one of two sequences: (A) triclosan-coated suture in the first surgery followed by non-coated suture in the second surgery, or (B) the reverse sequence. Standardized perioperative management is used across both periods to reduce procedural variability.
Masking is maintained for participants and outcome assessors. Allocation is concealed and documented for analysis after data collection. For each surgery, follow-up assessments are conducted during the first postoperative week using prespecified clinical evaluations and laboratory testing of a small collected suture segment, with consistent follow-up timing across both periods. Follow-up visits occur on postoperative days 3, 5, and 7 after each surgery.
The crossover design enables within-participant comparisons between suture types, reducing inter-individual variation in oral microbiota and healing response. The 4-week interval between procedures is intended to minimize carryover effects from the first surgery.
Each participant undergoes two separate surgical extractions of impacted mandibular third molars performed on different occasions 4 weeks apart. The operated side (right or left) may vary by case and is recorded; treatment assignment is based on surgery order (period 1 versus period 2). Participants are randomized to one of two sequences: (A) triclosan-coated suture in the first surgery followed by non-coated suture in the second surgery, or (B) the reverse sequence. Standardized perioperative management is used across both periods to reduce procedural variability.
Masking is maintained for participants and outcome assessors. Allocation is concealed and documented for analysis after data collection. For each surgery, follow-up assessments are conducted during the first postoperative week using prespecified clinical evaluations and laboratory testing of a small collected suture segment, with consistent follow-up timing across both periods. Follow-up visits occur on postoperative days 3, 5, and 7 after each surgery.
The crossover design enables within-participant comparisons between suture types, reducing inter-individual variation in oral microbiota and healing response. The 4-week interval between procedures is intended to minimize carryover effects from the first surgery.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: